Position Title: Quality Specialist
Department: Quality
Reports To: Quality Engineer
Workdays: Monday - Friday
Work Schedule: 8:00 am - 4:30 pm
Join our team and have a successful growing career with Health Care Logistics
!We have a casual and fun work environment with the necessary tools and resources to help you build success and growth within the company. HCL offers competitive compensation, including a great benefits package, as well as opportunities for professional growth and development. If you are a driven individual with a passion for quality, we would love to hear from you! Excellent work life balance - never take work home with you
!
Primary Functi
on
The position will inspect, sample, and test HCL products, packaging, and materials to ensure compliance with internal quality standards and external quality standards imposed by state and federal regulations. The position will have independent discretion and authority to stop orders from leaving the facility or from being placed into stock if they do not meet quality standards until such time as any issues are resolved. The position will lead and coordinate cross-functional teams to resolve any quality issues identified. The position has independent discretion and authority to initiate complaint investigations regarding quality control issues. Inspect, sample, and test products, packaging, and materials to ensure compliance with internal quality standards and external quality standards imposed by state and federal regulatio
- ns.
Independent discretion and authority to stop orders from leaving the facility or being placed into stock if they do not meet quality standards and until such issues are resol - ved.Independent discretion and authority to contact and coordinate with the purchasing department and send notices of non-conformance and/or complaints to manufactur
- ers.Independent discretion and authority to initiate complaint investigati
- ons.Train staff in Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP), and current procedures. The position will also assist in the development of procedures and training programs as nee
- ded.Maintain records and fi
- les.Document and escalate quality issues as they ar
- ise.Conduct periodic training for st
- aff.Writing, reviewing, and revising Quality Control documents, including but not limited to protocols, validations, method qualifications, standard operating procedures (SOPs), writing instructions (WIs) and technical repo
- rts.Maintain records and fi
- les.Lead cross functional documentation projects as requested and under the direction of the VP, Quality & Regulatory Aff
- airsWrite clearly and concisely to meet the needs of the target audie
- nce.Responsible for leading required training classes for quality and regulatory is
- suesEnsure compliance with corporate (SOPs) and regulatory requirements (e.g., GDP and c
- GMP)Conduct quarterly training for st
- aff.All other duties as assig
ned.
Require
- ments
BS/BA in Science degree preferred with 5 years of experience in a cGMP setting or 10 years of experience in a cGMP se - tting.Knowledge of current U.S. and international regulations pertaining to documen
- tationPrevious QA training is a
- plus.Excellent presentation, organizational and communication s
- kills.Multitasking a
- bilityAttention to d
- etail.Good interpersonal
- skillsExperience in medical device or pharmaceutical ind
- ustry.Familiarity with CFR 820 and/or ISO 13485 is a
- plus.Experience working in a self-driven, performance/results oriented, fast paced matrixed enviro
- nment.Excellent critical and analytical
skills
Benefits
Program
Our benefits are inc
redible!
We offer a benefits package that
- includes:
6 Pai - d HolidaysFull time benefits 1stof the month after 60 days of e
- mployment.Medical Insurance: We offer two medical plan options with low deductibles. Save more on premiums by qualifying for welln
- ess rates!Dental
- InsurancePrescription Drug Program with
- low copaysVSP Vision
- InsuranceFlexible Spendin
- g AccountsPaid time off - 7 vacation days and 8 personal days starting at your first full year of service (Prorated hours are given after 1stof the month after 60 days of e
- mployment)401(k) Retirement including 4% com
- pany matchCompany Paid Life
- InsuranceVoluntary Life Insurance available for you, your spouse, and you
- r childrenCompany Paid Short and Long-Term Disability
- InsurancesExtensive Bereavement Le
- ave PolicyEmployee Assistanc
- e ProgramsRainy Day Savin
gs Program
